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WO2005089868A1 - Dispositif de stimulation musculaire - Google Patents

Dispositif de stimulation musculaire Download PDF

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Publication number
WO2005089868A1
WO2005089868A1 PCT/GB2005/001033 GB2005001033W WO2005089868A1 WO 2005089868 A1 WO2005089868 A1 WO 2005089868A1 GB 2005001033 W GB2005001033 W GB 2005001033W WO 2005089868 A1 WO2005089868 A1 WO 2005089868A1
Authority
WO
WIPO (PCT)
Prior art keywords
stimulator
muscle
heart
projections
mother
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/GB2005/001033
Other languages
English (en)
Inventor
John Mark Morgan
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
INVIVO TECHNOLOGY Ltd
Original Assignee
INVIVO TECHNOLOGY Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by INVIVO TECHNOLOGY Ltd filed Critical INVIVO TECHNOLOGY Ltd
Publication of WO2005089868A1 publication Critical patent/WO2005089868A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/378—Electrical supply
    • A61N1/3785—Electrical supply generated by biological activity or substance, e.g. body movement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0587—Epicardial electrode systems; Endocardial electrodes piercing the pericardium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/37512—Pacemakers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/37518—Anchoring of the implants, e.g. fixation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/3756—Casings with electrodes thereon, e.g. leadless stimulators

Definitions

  • This invention relates to a device for stimulating contractile muscle, and is particularly concerned with human heart pacing.
  • Arrhythmia of the human heart is treatable by the use of a so called cardiac pacemaker, which is a device capable of delivering a periodic electric pulse to the heart, and which will cause the heart to beat synchronously.
  • Cardiac pacemakers are well known, are typically implanted subcutaneously. Means to connect the pacemaker to the heart and to an external energy source are required.
  • Leadless pacemakers have been proposed to eliminate the infection risk consequent on the use of a lead passing through the skin, but thus have the disadvantage that they must be removed for replacement or system revision. Furthermore, the energy source of a leadless pacemaker will become exhausted over time and require replacement, by surgery.
  • left ventricular pacing uses electrical leads that pass from the pacemaker to the left ventricular epicardial veins via the coronary sinus.
  • left ventricular epicardial pacing is employed.
  • a device for electrical stimulation of contractile heart muscle comprising a stimulator adapted for direct attachment to the external surface of the heart, and a mother device for remote mounting, wherein the stimulator and mother device are adapted for wireless communication, and the stimulator is self-powered.
  • the stimulator incorporates a motion driven device for generating electrical energy, and particularly a motion driven device directly responsive to movement of the heart muscle.
  • Such a device allows the stimulator to be of relatively small size, and thus adapted for direct placement on the epicardial surface of a human heart, using minimally invasive surgical techniques.
  • the mother device consists typically of those components which need not be placed against the muscle surface. In the case of heart pacing, such a mother device would for example be placed close enough to the stimulator for communication purposes, but in a location not requiring major surgical intervention. Typically the mother device would be mounted subcutaneously, but it could also be external to the body.
  • Communication between the stimulator and mother device is for example by low power radio frequency signal, but it is envisaged that other wireless techniques may also be suitable.
  • the required communication range is typically less than 100 mm.
  • the invention is particularly suitable for pacemakers because much of the current drain in conventional devices relates to diagnostics - typically data acquisition, data storage, and analysis of electrogram data - and not to generation of the pacing spike itself.
  • the stimulator is in effect an epicardial electrode whose function is in the preferred embodiment restricted to pacing, whilst the mother device comprises the other components and is adapted for access for programming, servicing, updating and so on.
  • Another advantage of the invention is that the signal transmission capabilities need only be very small, being restricted in the preferred embodiment to pacing alone.
  • the invention has the great advantage that the stimulator can be implanted without major trauma, is simple in construction, and thus likely to remain operable indefinitely, not least because replaceable batteries and the like can be avoided.
  • the stimulator is adapted for attachment by the use of a physiologically compatible adhesive, and muscle stimulation is via direct electrical contact between the stimulator and the surface to which it is in use attached.
  • the stimulator includes projections on the muscle side, which projections are adapted to mechanically engage the muscle surface, or be mechanically engaged by the muscle surface.
  • projections can be of any suitable shape and number, and are preferably in a regular array adapted to draw the stimulator into close intimate contact with the muscle surface. It is envisaged for example that a physiologically compatible adhesive may provide temporary retention, and that suitable projections provide a semi-permanent anchor after a few days. This technique allows functionality of the stimulator to be tested in vivo, and allows some freedom for re-positioning of the stimulator.
  • Projections of this kind assure intimate contact; and thus minimize the possibility for inflammatory material to accumulate or enter between the muscle surface and stimulator. Furthermore the stimulator can be adhered without causing trauma to the muscle surface. The avoidance of inflammatory material is also important in preventing stimulation of such inflammation as may occur.
  • the projections are electrically conductive, and adapted to pass an electrical stimulus into the muscle surface.
  • the projections may for example comprise an array of micro filaments adapted to interdigitate with the epicardial surface of the human heart.
  • Such conductive projections have the advantage of passing the electrical stimulus directly to the muscle, and thus the risk of attenuation by adhesive or unwanted interstitial material is avoided.
  • This micro-electrode technology facilitates pacing at low energy consumption as compared with conventional pacemakers.
  • the stimulator is preferably provided with a plurality of individually energizable electrical contact sites, which in the preferred embodiment are individual electrodes, or arrays of electrodes. Such a stimulator is thus adapted to deliver an electrical pulse to the muscle as a single event or as a succession of partial events.
  • the latter technique is especially suitable for causing a muscle to contract in a predetermined manner, for example by propagating a depolarization wavefront through the myocardium of the human heart.
  • the mother device may include a suitable programmable microprocessor.
  • a typical stimulator will be around 10 mm in diameter and may be a disc having a thickness of 3.5 mm. This size is suitable for placement in the epicardial space using endoscopic tools.
  • the stimulator may comprise a flexible strip attachable to the surface of contractile muscle and having a plurality of spaced electrodes along the length thereof.
  • the mother device is adapted to telemeter data to the stimulator.
  • the stimulator may also be adapted to provide feedback to the mother device, for example to achieve optimisation of a contraction prompted by sequential enegerization of electrodes.
  • the stimulator may also be adapted to sense and transmit information about the contact sites, including for example far field electrical signals, rhythm activity and events, temperature and tissue impedance.
  • the stimulator may be adapted to provide a contact electrogram, such as an electrocardiogram for the human heart.
  • the stimulator may include a buffer memory to allow such information to be downloaded to the mother device at periodic intervals, or on demand.
  • the stimulator is self-powered, and it may further include an energy storage device to provide stand alone operation for a limited period.
  • the energy storage device e.g. a capacitor
  • the motion driven device may be a generator of electrical current, such as a piezo-electric crystal.
  • a generator of electrical current such as a piezo-electric crystal.
  • Such a stimulator may thus be adapted to be entirely self-contained in the absence of the mother device.
  • the stimulator is generating only sufficient energy to produce a pacing pulse, which is a small requirement well within the capabilities of an generator driven by heart motion.
  • a small additional current drain might occur as a consequence of leadless communication with the mother device but this is within the capability of an integral motion driven generator and can be minimised by communicating with the mother device periodically, for example 1MS communication every 10MS operation.
  • the device would thus have a reduced resolution of pacing spike generation whilst not materially affecting efficacy of pacing or timing of pacing.
  • a suitable generator may comprise a piezo-electric crystal able to flex with heart motion so as to generate a current.
  • a generator could be of non-rigid materials.
  • Such a generator could comprise a resiliently suspended mass whose inertial response to movement results in relative displacement of charge inducing components with, for example, active rectification.
  • the stimulator further includes control means for generating a suitable pacing characteristic whereby the stimulator has the capability of being self-contained.
  • the control means may comprise a programmable ROM whereby the mother device can download or modify a suitable pacing characteristic so that pacing spikes are produced in a pre-determined manner.
  • a stimulator is attached to the epicardium of a human heart and comprises a fixing surface and a housing.
  • the fixing surface comprises a plurality of integrated projecting barbs arranged in a suitable array.
  • the barbs could be example be formed around the outer circumference, but they could equally well be formed in another pattern.
  • the tips of the barbs project so as to be engageable with the heart muscle to which the fixing surface is presented.
  • the number and design of barbs and the extent of projection is selected according to physiological requirements, the barbs being sufficient to anchor the fixing surface and to pass electrical stimulus to the heart muscle.
  • the fixing surface acts as a means by which an electrode assembly comprising anode and cathode may be placed in contact with the heart, and over time drawn into intimate contact with the epicardial surface.
  • Within the housing is provided electrical circuitry for energising the electrodes.
  • the stimulator is connected to an external control (mother) device without wires, and in one embodiment control (pacing) information is transmitted by e.g. radio frequency transmissions. Accordingly, within the housing may be provided a miniature receiver for such control transmissions.
  • a microgenerator responsive to movement of the heart to provide energy sufficient for generation of successive pacing pulses, and for control purposes.
  • the microgenerator typically comprises a resiliently suspended mass having an inertial response sufficient to cause relative displacement of charge inducing components.
  • the housing may further be provided with internal control circuitry whereby electrical pacing pulses are generated independently of an external control device.
  • internal control circuitry may be programmable by radio frequency transmission, and then set into action remotely.
  • the circuitry may typically include a RAM to hold externally provided pulsing information, a ROM to hold data concerning actual pacing events, and a transmitter to periodically transmit information from the ROM to an external device for analysis. Such analysis may permit a medical practitioner to reprogram the RAM or a programmable ROM so as to optimise pacing.
  • the housing may further include an energy storage device, such as a capacitor, to hold an energy reserve for the control circuitry, and/or for pacing.
  • an energy storage device such as a capacitor

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Cardiology (AREA)
  • Electrotherapy Devices (AREA)

Abstract

Selon l'invention, un dispositif d'entraînement cardiaque comprend un stimulateur qui est destiné à être placé directement sur le coeur et qui est auto-alimenté par un générateur entraîné par des mouvements, par exemple, un cristal piézo-électrique. Ledit stimulateur présente des protubérances entremêlées destinées à se fixer sur le muscle cardiaque et il peut être commandé ou programmé par un dispositif maître externe.
PCT/GB2005/001033 2004-03-18 2005-03-18 Dispositif de stimulation musculaire Ceased WO2005089868A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0406164.4 2004-03-18
GB0406164A GB2412069A (en) 2004-03-18 2004-03-18 Cardiac stimulation system having wireless communication to a stimulator directly attached to the external heart surface.

Publications (1)

Publication Number Publication Date
WO2005089868A1 true WO2005089868A1 (fr) 2005-09-29

Family

ID=32117993

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2005/001033 Ceased WO2005089868A1 (fr) 2004-03-18 2005-03-18 Dispositif de stimulation musculaire

Country Status (2)

Country Link
GB (1) GB2412069A (fr)
WO (1) WO2005089868A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12157003B2 (en) 2010-12-29 2024-12-03 Medtronic, Inc. Implantable medical device fixation

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140277231A1 (en) * 2011-11-24 2014-09-18 Laurent Berneman Medical device involving muscle stimulation electrodes and an electromagnetic lead
EP3789083A1 (fr) 2019-09-06 2021-03-10 BIOTRONIK SE & Co. KG Ancrage à base d'adhésif pour dispositifs médicaux implantables

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3456134A (en) * 1967-10-05 1969-07-15 Us Health Education & Welfare Piezoelectric energy converter for electronic implants
US5540729A (en) * 1994-12-19 1996-07-30 Medtronic, Inc. Movement powered medical pulse generator having a full-wave rectifier with dynamic bias

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4282886A (en) * 1979-11-13 1981-08-11 Medtronic, Inc. Adhesive bonded positive fixation epicardial lead
AU1159088A (en) * 1987-01-29 1988-08-24 S.B.M. Societa Brevetti Per La Medicina S.R.L. Epi-cardial electrode with an incorporated cardiac radio-frequency receiver (crr) for temporary heart stimulation from the outside, pre-arranged for permanent stimulation
JPH05245215A (ja) * 1992-03-03 1993-09-24 Terumo Corp 心臓ペースメーカ
US5476503A (en) * 1994-03-28 1995-12-19 Pacesetter, Inc. Sense array intelligent patch lead for an implantable defibrillator and method
US5814089A (en) * 1996-12-18 1998-09-29 Medtronic, Inc. Leadless multisite implantable stimulus and diagnostic system
US6141588A (en) * 1998-07-24 2000-10-31 Intermedics Inc. Cardiac simulation system having multiple stimulators for anti-arrhythmia therapy
AUPQ788400A0 (en) * 2000-05-30 2000-06-22 Wildon, Michael Peter Epicardial stimulation lead
US6445953B1 (en) * 2001-01-16 2002-09-03 Kenergy, Inc. Wireless cardiac pacing system with vascular electrode-stents

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3456134A (en) * 1967-10-05 1969-07-15 Us Health Education & Welfare Piezoelectric energy converter for electronic implants
US5540729A (en) * 1994-12-19 1996-07-30 Medtronic, Inc. Movement powered medical pulse generator having a full-wave rectifier with dynamic bias
EP0974377A1 (fr) * 1994-12-19 2000-01-26 Medtronic, Inc. Redresseur à double alternance à polarisation dynamique

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12157003B2 (en) 2010-12-29 2024-12-03 Medtronic, Inc. Implantable medical device fixation
US12268868B2 (en) 2010-12-29 2025-04-08 Medtronic, Inc. Implantable medical device fixation
US12268867B2 (en) 2010-12-29 2025-04-08 Medtronic, Inc. Implantable medical device fixation

Also Published As

Publication number Publication date
GB2412069A (en) 2005-09-21
GB0406164D0 (en) 2004-04-21

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